G/LIC/N/2/TON/7  
 
24 August  2021 
(21-6388) Page: 1/4 
Committee on Import Licensing    
 
 
AGREEMENT ON IMPORT LICENSING PROCEDURES  
NOTIFICATION UNDER ARTICLE 5.1 TO 5.4 OF THE AGREEMENT1 
TONGA  
The following notification dated 16 August  2021, is being circulated at the request of the delegation 
of Tonga .  
_______________  
 
THERAPEUTIC GOODS ACT [CAP.12.16]  
 Category  Notification details  
1 Notifying Member  Tonga  
2 Title of new legislation/ 
procedure  Therapeutic Goods Act [CAP.12.16]  
3 Date of Publication  11th July 2001  
4 Date of entry into force  1st July 2010  
5 Website link/Official 
publication of the new 
regulation/procedure  Therapeutic Goods Act (ago.gov.to)   
6 Have you attached a copy 
of the regulation (PDF) to 
the Secretariat  [x] Yes. ( Please attach a copy of the regulation to the notification. ) 
 
[ ] No.  
7 Type of notification  [x] (a) New licensing regulation/procedure2; (please answer question 
8 to 14)  
 
[ ] (b) Changes to a regulation/procedure which has been previously 
notified in document; ( please answer question 15 and 16 ) 
8 List of products subject to 
licensing  Registered List : 
Class 1: Medicinal drugs available from licensed retail outlets;  
Class 2: Medicinal drugs available from registered pharmacy premises 
under the supervision of a registered pharmacist, divided into –  
Class 2A: Where advice of pharmacist at point of sale is not required;  
Class 2B: Where advice of pharmacist at point of s ale is required;  
Class 3: Medicinal drugs available on prescription only and dispensed 
by a pharmacist or assistant pharmacist;  
Class 4: Medicinal drugs available on special prescription only and 
dispensed by a pharmacist or assistant pharmacist;  
Class 5: Narcotic drugs and psychotropic substances subject to 
special import controls;  
Class 6: Medicinal drugs available from veterinary practitioners for 
animal use.  
 
1 It is understood that the notifying Member has also completed its notification obligations under 
Article  1.4(a) and Article 8.2(b) regarding the relevant law/regulation/procedure notified for by filling this form 
in a full and complete manner.  
2 "New licensing regulation/procedure" is understood to refer to any newly introduced law, regulation or 
procedure, and those which are in force but being notified for the first time to the Committee.  
 G/LIC/N/2/TON/7  
 
- 2 - 
 
   Category  Notification details  
9 Nature of licensing  Automatic: [ ]  
 
Non-Automatic: [ x] 
10 Administrative 
purpose/measure being 
implemented  (a)  Protect public morals;  
(b)  Protect human, animal or plant life and health; protect 
environment;  
(c)  Collect trade statistics or market surveillance;  
(d)  Protection of patents, trademarks and copyrights, and 
the prevention of deceptive practices;  
(e)  Pursue obligations under the UN Charter and other 
international treaties ( i.e. CITES, Basel Convention, 
Rotterdam Convention, UNSC Resolutions etc.)  
(f)  Quota (including TRQ) administration;  
(g)  Regulate imports of arms, ammunition or fissionable 
materials and safeguard national security;  
(h)  Other: ______________ (please specify)  
11 Administrative body(ies) 
for submission of 
applications   
 Ministry/authority and Department: Ministry of Health  and 
Pharmaceutical Department  
Address: Drug Regulatory Authority, Pharmaceutical Department, 
Baron Road, Vaiola Motu 'a, Nuku 'alofa  
Website: http://www.health.gov.to/   
Telephone: (+676) 24553/ 7400200  
E-Mail: tongadrugregulatory@gmail.com   
12 Contact point for 
information on eligibility  Ministry/authority and Department: Ministry of Health  and 
Pharmaceutical Department  
Address: Drug Regulatory Authority, Pharmaceutical Department, 
Baron Road, Vaiola Motu 'a, Nuku 'alofa 
Website: http://www.health.gov.to/   
Telephone: (+676) 24553/7400200  
E-Mail: tongadrugregulatory@gmail.com   
13 Expected duration of 
licensing procedure  Ongoing  
 
14 A summary of the 
notification in one of the 
WTO official languages   This Act is to establish a system of regulation of therapeutic goods, to 
establish a national drugs and medical supplies committee, to 
regulate the import  of quality, safety, efficacy, affordability, 
availability and use of registered therapeutic goods, including narcotic 
drugs and psychotropic substances and for ancillary purposes.   
15 In the case of 7(b), please 
indicate the type of new 
change(s)  (a)  Termination  
(b)  Suspension  
(c)  Modification of specific details in existing  
procedures:  
 Product coverage;  
 Administrative purpose;  
 Automatic or Non -automatic;  
 Duration of licensing;  
 Change the nature of quantity/value restriction;  
 Eligibility of applicants;  
 Contact information on eligibility;  
 Administrative body(ies) for submission of application;  
 Documentation requirements (including application form);  
 Period for Application;  
 Administrative body(ies) to issue licence;  
 Processing time for issuing licence;  
 Licence fee/administrative charge;  
 Deposit/advance payment and relevant conditions;  
 Appeal regulations/procedures;  
 Validity of licence;  G/LIC/N/2/TON/7  
 
- 3 - 
 
   Category  Notification details  
 Other conditions of licence (extension, transferability, 
penalty of non -use etc.);  
 Foreign exchange requirements;  
 Other: __________ (please specify).  
 
16  Please elaborate the 
changes in detail (in one 
of the WTO official 
languages)   
 
 
THERAPEUTIC GOODS REGULATIONS  [CAP.12.16.01]  
 Category  Notification details  
1 Notifying Member  Tonga  
2 Title of new legislation/  
procedure  Therapeutic Goods Regulations [CAP.12.16.01]  
3 Date of Publication  11 June 2011  
4 Date of entry into force  16 June 2011  
5 Website link/Official 
publication of the new 
regulation/procedure  Therapeutic  Goods Regulations 2011 (ago.gov.to)   
6 Have you attached a copy 
of the regulation (PDF) to 
the Secretariat  [ ] Yes. ( Please attach a copy of the regulation to the notification. ) 
 
[x] No. 
7 Type of notification  [x] (a) New licensing regulation/procedure3; (please answer question 
8 to 14)  
 
[ ] (b) Changes to a regulation/procedure which has been previously 
notified in document ; (please answer question 15 and 16 ) 
8 List of products subject to 
licensing  Registered List : 
Class 1: Medicinal drugs available from licensed retail outlets;  
Class 2: Medicinal drugs available from registered pharmacy premises 
under the supervision of a registered pharmacist, divided into –  
Class 2A: Where advice of pharmacist at point of sale is not requ ired; 
Class 2B: Where advice of pharmacist at point of sale is required;  
Class 3: Medicinal drugs available on prescription only and dispensed 
by a pharmacist or assistant pharmacist;  
Class 4: Medicinal drugs available on special prescription only and 
dispensed by a pharmacist or assistant pharmacist;  
Class 5: Narcotic drugs and psychotropic substances subject to 
special import controls;  
Class 6: Medicinal drugs available from veterinary practitioners for 
animal use.  
9 Nature of licensing  Automatic: [ ]  
 
Non-Automatic: [ x] 
10 Administrative 
purpose/measure being 
implemented  (a)  Protect public morals;  
(b)  Protect human, animal or plant life and health; protect 
environment;  
(c)  Collect trade statistics or market surveillance;  
(d)  Protection of patents, trademarks and copyrights, and 
the prevention of deceptive practices;  
(e)  Pursue obligations under the UN Charter and other 
international treaties ( i.e. CITES, Basel Convention, 
Rotterdam Convention, UNSC Resolutions etc.)  
(f)  Quota (including TRQ) administration;  
 
3 "New licensing regulation/procedure" is understood to refer to any newly introduced law, regulation or 
procedure, and those which are in force but being notified for the first time to the Committee.  
 G/LIC/N/2/TON/7  
 
- 4 - 
 
   Category  Notification details  
(g)  Regulate imports of arms, ammunition or fissionable 
materials and safeguard national security;  
(h)  Other: ______________ (please specify)  
11 Administrative body(ies) 
for submission of 
applications   
 Ministr y/authority and Department : Ministry of Health  and 
Pharmaceutical Department  
Address: Baron Road, Vaiola Motu 'a, Ministry of Health, Nuku 'alofa 
Website: http://www.health.gov.to/  
Telephone: (+676) 24553/ 7400200  
E-Mail: tongadrugregulatory@gmail.com   
12 Contact point for 
information on eligibility  Ministr y/authority and Department:  Ministry of Health and 
Pharmaceutical Department  
Address: Baron Road, Vaiola Motu 'a, Ministry of Health, Nuku 'alofa  
Website: http://www.health.gov.to/  
Telephone: (+676) 24553/ 7400200  
E-Mail: tongadrugregulatory@gmail.com   
13 Expected duration of 
licensing procedure  Ongoing  
 
14 A summary of the 
notification in one of the 
WTO official languages   In exercise of the powers conferred by section 35 of the Therapeutic 
Goods Act 2001, the Minister of Health with the consent of Cabinet 
has made th ese Regulations.  
15 In the case of 7(b), please 
indicate the type of new 
change(s)  (a)  Termination  
(b)  Suspension  
(c)  Modification of specific details in existing  
procedures:  
 Product coverage;  
 Administrative purpose;  
 Automatic or Non -automatic;  
 Duration of licensing;  
 Change the nature of quantity/value restriction;  
 Eligibility of applicants;  
 Contact information on eligibility;  
 Administrative body(ies) for submission of application;  
 Documentation requirements (including application form);  
 Period for Application;  
 Administrative body(ies) to issue licence;  
 Processing time for issuing licence;  
 Licence fee/administrative charge;  
 Deposit/advance payment and relevant conditions;  
 Appeal regulations/procedures;  
 Validity of licence;  
 Other conditions of licence (extension, transferability, 
penalty of non -use etc.);  
 Foreign exchange requirements;  
 Other: __________ (please specify).  
 
16  Please elaborate the 
changes in detail (in one 
of the WTO official 
languages)   
 
 
__________